Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome

Fred Hutchinson Cancer Center

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.

OBJECTIVES: * Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell transplantation. * Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen. * Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen. * Determine the incidence of relapse in these patients treated with this regimen. OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or unrelated compatible donor. PBSC are selected for CD34+ cells. Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily (if feasible) until day 51 followed by a taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Patients are followed through day 100, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Leukemia Myelodysplastic Syndromes

Interventions

busulfanDRUG

cyclophosphamideDRUG

cyclosporineDRUG

methotrexateDRUG

Eligibility

Sex: ALLMax age: 65 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of low or intermediate-risk myelodysplastic syndrome * Refractory anemia (RA) * RA with ringed sideroblasts * No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid) * No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex abnormalities) * HLA-A, B, C, DRB1, and DQB1 compatible related or unrelated donor available * Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * AST no greater than 2 times normal Renal: * Creatinine no greater than 2 times upper limit of normal * Creatinine clearance at least 50% Cardiovascular: * No cardiac insufficiency requiring treatment * No symptomatic coronary artery disease Pulmonary: * No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted) * No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted) Other: * No other disease that would limit life expectancy * HIV negative * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Locations (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Data from ClinicalTrials.gov

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